STEALTH SURGICAL IRRIGATOR ASPIRATOR
FDA 510(k) clearance K930511 · decided 1993-06-25
Clearance details
- K-number
- K930511
- Device name
- STEALTH SURGICAL IRRIGATOR ASPIRATOR
- Applicant
- W. J. Medical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-02-01
- Decision date
- 1993-06-25
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Newbury Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufac recall (Z-0114-2008) | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK | 2007-11-07 |
| Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 10 recall (Z-1150-2007) | Zinnanti Surgical Design LLC | 2007-08-14 |